CTIS2023-506853-39-00招募中1 期
Treatment of adynamic bone disorder with parathyroid hormone in patients with chronic kidney disease - 20192022
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Age =18 years, CKD stage 4-5D (eGFR =29 ml/min) according to KDIGO (Kidney Disease Improving Global Outcome) definition, DEXA scan with a T-score at the total hip, femoral neck or lumbar spine (L1-4) =-2 (or Z-score =-2) in a minimum of 2 vertebrae (for patients with active oral prednisolone treatment = 5 mg/day for minimum 3 months the T-score or Z-score limit is <-1) and/or former fragility fracture (vertebral, hip, for- or upper arm, ankle) assessed with VFA or x-ray of the columna, Patients with expected adynamic bone disorder, based on BSAP=21 µg/l (11) or biopsy-verified low bone turnover
排除标准
- •Hypercalcemia defined as sustained ionized calcium >1.35 mmol/l, Drug or alcohol abuse, Previous fracture within the last 6 months (Patients may be rescreened after the 6 months), Unable to participate in a clinical study based on the judgement by the local investigator, For those participating in the bone biopsy procedure: 1) Hypersensitivity to any of the tetracyclines or to any of the excipients or content, 2) Treatment with anticoagulants (vitamin K antagonists, NOAC, unfractionated or low-molecular heparin or antiplatelet agents that, due to clinical indication, can’t be paused 3) Disturbances in thrombosis and/or haemostasis, For those participating in pulse wave measurements: 1) Atrial fibrillation, 2) Aorta stenosis, Previous calciphylaxis, Thyroid disturbances not adequately treated based on the opinion by the clinician (Patients may be rescreened after treatment optimization), Treatment with digoxin, Paget’s disease or other metabolic bone disorders, Antiresorptive or bone anabolic medication during the last 24 months (for bisphosphonates it is only during the last 12 months), Patients who have undergone a kidney transplantation within the last 12 months, Former or present malignant disease (except skin basal or planocellular carcinoma), Previous external beam or implant radiation therapy to the skeleton, 25 hydroxyvitamin D2 and D3 <50 nmol/l (Patients may be rescreened after correction), Inability to administer teriparatide, Reduced liver function (ALAT >3x upper limit of normal or bilirubin > 2x upper limit of normal), Pregnancy, lactation or fertile women (Post-menopausal females are not considered fertile) not using safe anticonception (the following contraceptive methods are considered appropriate: Intrauterine device (IUD) or hormonal anticontraceptive (oral contraceptives, implant, transdermal patches, vaginal ring or depot injection))., Hypersensitivity to the active substance in teriparatide or to any of the excipients or content, Inability to provide informed consent, Medical conditions or treatments that may interfere with assessments of the outcomes of the trial
研究者
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